Ardelyx - Earnings Call - Q4 2021

Transcript

Speaker 0

Good afternoon, and welcome to Ardellixis Fourth Quarter and Year End twenty twenty one Conference Call. At this time, all participants are in a listen only mode. There will be a question and answer session after the prepared remarks. As a reminder, today's call is being recorded. I would now like to turn the call over to Justin Brenz, Chief Financial Officer of Ardellix.

Sir, you may now begin.

Speaker 1

Thank you. Good afternoon, everyone, and welcome to our first financial results call, a practice we intend to implement going forward as we march toward becoming a commercial stage company. During this call, we will refer to the press release issued earlier today, which is available in the Investors section of the company's website at ardellix.com. On the call with me today are Mike Robb, President and CEO and Susan Rodriguez, Chief Commercial Officer Doctor. Laura Williams, Chief Medical Officer Doctor.

David Rosenbaum, Chief Development Officer and Rob Blanks, Chief Regulatory Affairs and Quality Assurance Officer, will join us for the question and answer period. During this call, we will be making forward looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described. We encourage you to review our risk factors in our annual report on Form 10 ks, which we filed today. It also can be found on our website at ardellix.com.

While we may elect to update these forward looking statements in the future, we specifically disclaim any obligation to do so even if our views change. With that, let me pass the call over to Mike.

Speaker 2

Thank you, Justin, and good afternoon, everyone. It's exciting for me to kick off what will now be quarterly calls on the eve of launching our commercial product, IZRELA, in the coming weeks. What is so important to understand about IZRELA is that it represents a significant advance in innovation for treating irritable bowel syndrome with constipation in adults. With over 5,000,000 prescriptions written annually, there remains a significant unmet need for many of those patients. Compared to current treatment choices, IBSRELA provides a unique mechanism of action, offering physicians and patients a different option to address the debilitating impact of IBS C.

Today's dynamics around the IBS C market and particularly with IBSRELA make it a very compelling opportunity for patients, the company and our shareholders. This is a significant inflection point for Ardellix, and we are excited to bring our innovative product to market as a commercially focused organization. I would like to review a few key points. Number one, we see a highly favorable dynamics as we prepare for launch. The IBS C market has been cultivated and expanded over the past ten years and is ripe for a differentiated product with a unique mechanism of action.

Two, the established prescription market includes over one point six million IBS C patients treated with currently available therapies, with at least thirty five percent of whom are inadequately managed and in need of effective treatment alternatives. Three, this is a highly concentrated market with 9,000 physicians responsible for approximately 50% of the over 5,000,000 annual scripts for IBS C. This is a dynamic that is ideal for our focus, targeted, specialized sales force, all of whom have been hired, trained and are preparing for launch. And four, based on thoughtful, well considered assumptions of mid to high single digit penetration in the IBS C market, we expect to achieve peak annual net revenue of over $500,000,000 with a clear path ahead of us to achieve breakeven and ultimately profitability for the product, which we believe will create significant shareholder value. Susan will review our ABSRELLA launch plans in more detail later on the call.

But before that, I'd like to update you on the progress we are making at the FDA with our formal dispute resolution efforts for hyperfuspaterceptinor and hyperphosphatemia. To remind you, our initial appeal was filed with the FDA's Office of Cardiology, Hematology, Endocrinology, Nephrology on December second of twenty twenty one. Following an information request from the office on December 22, we submitted additional analyses on January seventh of this year. As we had anticipated on February 4, we received an appeal denial letter from the office. Also in February, we then filed our second appeal to the Center for Drug Evaluation and Research, Office of New Drugs.

If accepted for consideration, we expect a decision on the second appeal in April of this year, and we'll keep you updated as progress is made. Meanwhile, Koya Kirin, or KKC, our partner for tenapanor in Japan has now completed three of four planned Phase III studies in adult patients on dialysis. And although we're not yet able to disclose the results of their studies, on February 7, KKC announced positive results from one of their Phase III studies and their plans to file for approval of tanezanor in Japan in the second half of 'twenty two with potential regulatory clearance in the second half of twenty twenty three. Tinapinol continues to offer great promise as an important and novel treatment for hyperphosphatemia for adult patients with chronic kidney disease on dialysis. The comprehensive clinical data generated for tsunapimod in this indication are consistent and support that safety and efficacy is a twice daily oral therapy.

We will continue to push the FDA dispute resolution process on behalf of patients and their treating physicians, whom we know deserve better therapeutic alternatives to address the challenges of managing serum phosphorus. In addition, we continue to advance our small molecule potassium secretagog program, RDX-thirteen, as a potential treatment for hyperkalemia. We are in the process of evaluating the efficacy, safety and pharmacodynamics of RDX-thirteen in adult patients with hyperkalemia from our Phase II study, with the next steps to be determined based on the final analyses of these results, continued formulation development, and sufficient financial resources. We also continue to make progress with our RDX-twenty program, a bicarbonate exchange inhibitor, to treat metabolic acidosis, a highly prevalent comorbidity in CKD patients that is strongly correlated with disease progression and adverse outcomes. We have identified lead compounds that are potent, selective and proprietary inhibitors of bicarbonate secretion.

We continue to advance this program utilizing third party CROs. To summarize, Ardellis is well positioned with an approved product launching in a large market with few competitors, a strong pipeline of internally discovered drug candidates, a talented team that will drive our success, and an anticipated revenue stream that has the potential to transform the company into a profitable entity. To that end, I believe that we are uniquely poised to weather projected near term market volatility with much higher probability for long term success. Now I'd like to pass the call to Susan to share details on the launch. Susan?

Speaker 3

Thanks, Mike. Our team is excited and ready to execute a successful launch of IZRELA. The market need is clear. We can efficiently reach key prescribers, and our research confirms that the novel mechanism and strong efficacy data of IBSRELA will fuel market receptivity. Over the past decade, the introduction of GCC agonists has transformed the management of IBS with market building investments converting what was once an OTC market to an established prescription therapy market.

The market basket of IBS C indicated products includes LINZESS, TRULANCE, AMITIZA and ZELNORM, with the market increasingly consolidated around two branded therapies that combined have 84 market share. Despite active use of these therapies, HCPs persistently report that over a third of patients under their care continue to have symptoms and are considered to be inadequately managed. This relatively uncluttered market with a stated need for expanded therapeutic options is an ideal opportunity for IBSRELA with its novel mechanism and compelling and differentiated clinical profile. All key commercial elements needed to drive the successful launch of IBSRELA are in place. We are ramping up our product supply and have mobilized our highly experienced specialty sales force and commercial team to engage with our targeted high riders, introduce Ardellix and inform them that IBSRELA is coming soon.

Our

Speaker 4

go

Speaker 3

to market plan and strategy for IBSRELA is informed by comprehensive market research and analysis. Our commercialization focus is on physicians who are high prescribers of the GCC agonist, targeting the patients that are currently under their care. Our research showed that fifty six percent of high prescribers consider IBS C to be a difficult condition to treat, and eighty three percent reported a significant unmet need with more than one third of patients currently being treated with prescription therapies continuing to suffer from symptoms of IBS C. The dissatisfaction centered on the efficacy parameters of abdominal pain and bloating. Seventy five percent of high prescribers reported a favorable response to the IBSRELA profile, rating its novel mechanism and efficacy data as the most compelling attributes and projected use of IBSRELA in a meaningful subset of their patients.

Key elements to our commercialization strategy include, one, leveraging the market need for expanded therapeutic options to treat IBS C. Our commercial efforts will be centered on high riding HCPs for patients where the novel mechanism and clinical profile represented by IBS C would provide an attractive therapeutic alternative. Two, IBS C will be positioned as a first in class NH E3 inhibitor with a triple action in treating IBS C. Three, messaging will emphasize the Idrella MOA is differentiated from existing therapies and the clinical data that demonstrates significant improvement in abdominal pain, bloating, and constipation with a quick onset of action and sustained efficacy. Messaging will also emphasize the demonstrated clinical results of improved patient quality of life versus placebo and patient reported treatment satisfaction.

This positioning and messaging focus will establish Ibsrela with its new mechanistic approach and triple acting effect as a meaningful new tool in the treatment toolkit for HCPs who treat patients with IBS Four, our sales force efforts targeted at the highest writers will be further amplified by omnichannel tactics, leveraging the rapidly advancing dynamics in the marketplace on how and where HCPs receive their information. Five, we will have broad based distribution, including retail and specialty channels to accommodate office and patient preferences on where they wish to pick up their prescription and to align to their existing processes for handling specialty products. Six, we have set the price for IBSRELA based on the value it will provide patients in this established therapeutic space with a limited number of options and a recognized unmet clinical need. Within the IBS market pricing landscape, which ranges from $450 a month to $2,200 a month, we have set the launch price for IBSRELA to be $1,500 per month. As you think about the first few months and quarters of the launch, here's what to expect.

We will be stocking the channel early in Q2. Throughout Q2 and through Q4, our sales force will be focused on the highest riders with a key focus on the highest riding GIs to build the foundation of use for IBSRELA to support continual expanded use. IBSRELA will have a strong commercial and clinical data presence at the largest GI conference, Digestive Disease Week that will take place Q2 in San Diego. We will be working with payers to secure access for IBSRELA. As a novel product, our access strategy is centered on the value proposition of addressing the existing clinical unmet need among actively treated patients and rebating not to match existing agents, but to minimize the step through requirements.

We will leverage the current processes in place in GI offices that are well established to address access requirements for the agents commonly prescribed in a GI practice, agents to treat IBS C, IBS D, ulcerative colitis, Crohn's disease and HCV are all therapeutic areas associated with payer restriction. Uptake of IBS DRELA over the first few quarters will be enabled by the pent up demand of IBS C patients currently under the care of an HCP that are inadequately managed and good candidates for treatment with IBS DRELA, counterbalanced by access ramp up challenges and the criticality of the HCP demand motivation to work through payer hurdles. As Mike mentioned, our promotional focus will be centered on the 9,000 high riding physicians who account for approximately fifty percent of prescriptions written for drugs indicated for IBS C. With a targeted specialty sales force, full company engagement and innovative omnichannel peer to peer and digital initiative, we will bring in XERRALA to the patients being actively managed today who are in need of additional treatment options. From a payer landscape perspective, prior authorizations and step therapy protocols for novel entrants are standard for this market today, with HCPs having to attest to the fact that patients are not adequately responding to preferred agents.

We expect that payers will put in place step therapy requirements for IBSRELA. We consider these payer challenges to be addressable on the basis of four key considerations. One, the patient need for IBSRELA. Two, HCP demand for IBSRELA. Three, HCP familiarity and experience in addressing the step hurdles implicit in the space.

And four, the comprehensive customer service support we will have in place to support physician offices. In parallel, we will work to put in place contracts to secure access and minimize step therapy requirements. We are within weeks of launching IBSRELA and are thrilled to bring this much needed, highly differentiated therapy to market and most importantly, to make a difference in the lives of patients who are suffering from IBS I will now turn the call over to Justin to review our Q4 and year end 2021 financials. Justin?

Speaker 1

Thank you, Susan. At the end of the fourth quarter of twenty twenty one, we had total cash, cash equivalents and short term investments of $116,700,000 as compared to total cash, cash equivalents and investments of $188,600,000 as of 12/31/2020. As announced last week, we paid off our existing debt with Solar Capital Limited and the Life Sciences Group at Bridge Bank in full, and we have now entered into a new term loan with SLR Capital Limited for $27,500,000 with two years interest only and an option for an additional $22,500,000 in term loan debt if Exposa receives approval in certain other conditions. We generated $10,100,000 in revenue for the year ended 12/31/2021, an increase of $2,500,000 or 33% compared to 7,600,000.0 for the year ended 12/31/2020. The increase in our revenue was primarily attributable to a $5,000,000 development milestone, which we earned upon the initiation of Phase III clinical studies in Japan by KKC to evaluate tinapronor for hyperphosphatemia.

Research and development expenses were $91,100,000 for the year ended 12/31/2021, an increase of $26,100,000 or 40% compared to $65,100,000 for the year ended 12/31/2020. The increase in our R and D expenses was primarily the result of tinapril manufacturing costs as we prepared for the launch of IMDRELA, and should we be successful in our appeal, The U. S. Launch of XPOVISA. In late twenty twenty one, we eliminated our research group.

And so in 2022, we expect our research and development expenses to be significantly lower than in 2021. R and D expenses for 2021 also included $2,700,000 in severance payments and other employee related restructuring costs. Selling, general and administrative expenses were $72,300,000 for the year ended 12/31/2021, an increase of $39,200,000 or 118% compared to $33,200,000 for the year ended 12/31/2020. The increase in general and administrative expenses was primarily due to an increase in costs associated with building and staffing our commercial infrastructure as we prepare for the potential regulatory approval and U. S.

Launch of XPOVIO. General and administrative employee related expenses also included $3,500,000 in severance payments and other employee related restructuring costs. As Susan discussed, we have a focused EXPAREL commercial launch plan. And as a result, we expect our 2022 SG and A expenditures to be slightly less than in 2021. Net loss for the year ended 12/31/2021 was $158,200,000 compared to $94,300,000 for the year ended 12/31/2020.

We will address our operating cash flow requirements with our current cash and investments, revenue generated from sales of VIBRALA, our potential receipt of anticipated milestone payments from our collaboration partners, prudent cash management and the potential to access the capital markets. In addition to our debt refinancing, we are actively pursuing other non equity solutions to extend our cash runway further into 2023 to support our planned operations, support the Ibsrela launch, and we have a lot of confidence in our ability to fund these operations. Today, we received notice from NASDAQ that our bid price has closed below $1 for thirty consecutive trading days. We received a deficiency notice that advises that we can afford a compliance period of one hundred and eighty calendar days to regain compliance with the applicable NASDAQ listing requirements. If we fail to regain compliance with NASDAQ's continued listing requirements, NASDAQ may take steps to delist our common stock or to move us from the NASDAQ Global Market tier of companies to the NASDAQ Capital Markets tier.

We plan to take action to avoid such a delisting and to restore our compliance with NASDAQ's listing requirements. Additional disclosures are included in our Form 10 ks, which we filed today. I will now turn the call back over to Mike for some concluding comments before we open the call for questions. Mike?

Speaker 2

Thanks, Justin. Despite some of these recent challenges, this is a monumental time for Ardellix as we enter an important evolution to a commercial stage company. We are enthusiastic to enter the marketplace and offer patients with IBS C a much needed novel mechanism therapy. This transition differentiates us in the biopharma industry now as a revenue generating company with a clear line of sight to breakeven for IBS C and ultimately profitability for the product, which we believe will create significant shareholder value. We will have a strong and capable commercial presence and will be poised from a position of strength where additional commercial products could be leveraged, including the support of potential launch of tinapin or hyperphosphatemia upon a successful outcome of the formal dispute resolution process.

Given what many would characterize as a tumultuous 2021 for ardellics, our pipeline diversification and visionary strategies have positioned us well for near term and future growth. We believe that our focus on the patient and developing medicines to help them live longer and better lives will be successful for the patients and ultimately for our shareholders. We look forward to keeping you apprised of our progress. And now with that, I will open the call to questions. Jesse?

Speaker 0

Thank you, speakers. Participants, we will now begin the question and answer session. Speakers, our first question is from the line of Chris Freeman of Piper Sandler. Your line is now open.

Speaker 5

Hey guys, thanks for taking the question. I guess I need to ask, A couple of weeks ago you guys had an eight ks where you highlighted, you know, the outcome here and appeal to the Office of New Drugs. But I guess I was pretty intrigued by the language around, you know, potentially having a path to resubmit without running new trials. I mean, guess I'm just kind of curious. There's no mention of that pathway here in this call.

So can you maybe give a little bit of color? Is that path still open? You know, where does that stand, I guess, Sure. First and

Speaker 2

Thanks for the question. No, that path still exists, we expect. You know, but we've been consistent in is saying that we believe any sort of positive outcome is gonna come through CEDAR and OND. So rather than go through the process at OCHAN, it made sense to then pick it upstairs as we've talked in the past and go through, with them the process to hopefully be able to overturn the CDRL. So our our assumption is that alternative is still there.

It opened up a door that I think strengthens the process we're going through now through OND, which was the strategy that we had said at the beginning that we would pursue.

Speaker 5

Okay. So just so I understand the sequence then, so, you go through the process with the Office of New Drugs. You get your answer in April. And then depending on that answer or the decision, pursue the, the path of resubmitting based on some subset of the data that

Speaker 2

you already have? Is that right? So I'll ask Rob Blanks to add a little bit more color. But the outcomes can be rejection. It can be overturning and remanding to cardio renal.

It could be additional information requests, or it could be advisory committee. Right? So those are kind of generally the outcomes that could be there. And in those could be additional analyses as we suggested in our filings. Obviously, we don't have any way of predicting what it's gonna be standing where we are now.

But the other nuance is, if it's a two month versus a six month submission, because we don't have an active NDA. So we would have to resubmit in order to have discussions. Rob, anything to add?

Speaker 6

No, Mike. I think you have it covered pretty well. I mean, that path still exists. Obviously we feel that, you only have one chance to go up to a higher level, and we felt that that was the the best way to go. And certainly we did not think that the OCHN with Doctor.

Jaffe who's relatively new to that position would overturn them. So we still think we have a chance with the OND.

Speaker 5

Great. Okay. Thank you very much.

Speaker 0

Next question is from Tetan Bonsak of Cowen.

Speaker 7

This is Tetan on for Joe. So kind of following up on that, how would you plan or would balance any additional investment in the hyperphosphatemia program with the potential inclusion in the dialysis bundle and if the 2025 time frame for inclusion is still likely to stand? And then I've got a follow-up as well.

Speaker 2

Sure. I mean, I think we're taking this in a stepwise fashion. You know, we believe wholeheartedly that patients deserve this drug, first and foremost. And, you know, as we were speaking over the past that, you know, the opportunity that exists even in a bundled scenario, we think allows for a great opportunity commercially. We believe there continues to be an opportunity to extend the exclusion.

That work is ongoing. So lots of different, obviously, balls in the air, but additional investments in EXFOSA would depend upon what that looked like. I think we have been consistent in saying doing what was implied in the CRL, of doing an outcome study is not on the table. There's no other phosphorus lowering therapy that has ever been required to do that, and that is a big part of the basis of of our FDRR. So we continue to be committed to seeing this through.

Anyone who knows me knows that I'm stubborn and wanna find a path to get this product to the patients who so need it.

Speaker 7

Thank you. That's, really helpful. And then kind of the second question kind of more on its relevant Europe. What are kind of the plans? Have there been any discussions in partnership, or do you plan on potentially, launching that yourself?

Speaker 2

No. I I think we'll wait and see how we do here, begin the conversations with folks that have reached out, and we'll reach out to other folks as well. I mean, we're a relatively small team doing a lot and wanna focus on The US launch before, distracting ourselves and trying to do those.

Speaker 7

Alright. Thank you so much.

Speaker 2

Sure. Thank you, Tate.

Speaker 0

Next question is from Laura Chico of Wedbush Securities. Your line is now open.

Speaker 1

Hi. So this is Sam on for Laura Chico. I'm wondering, at this point for the Ibsrela launch, what are the key gating factors to launching in the second quarter? And then I'm just wondering if your view on market positioning, in the few months that you've had to prepare has changed at all.

Speaker 2

Yes. So let me just give a couple of comments, and I'll pass it off to Susan. We would have launched ADRELA sooner, had we had the material. Right? We were focused on the Exposa launch, those tablets.

So we had to shift our efforts, to make the fifty milligram tablets. And that's really been the gating issue for us in preparation for launch. I will ask Susan to address your the second part of your question. I I would say that my conviction for what Susan has described the opportunity to be has only increased over the months and and is in no way decreased given the dynamics of that market marketplace. Susan?

Speaker 3

Yes. Thanks, Mike. Yes. We as a commercial team, I mean, the commercial capabilities for Argelic have been ramping up over the last eighteen months. And part of building out a commercially facing company, we've attracted phenomenal talent, very experienced talent in the industry with bringing new products to market.

And the first thing we did was very thoroughly evaluate our portfolio of assets and do the market research to understand the relative opportunity of each of those assets and how which then directs our thinking around optimizing those assets, which implicit in that is the go to market strategy positioning and messaging for IZRELA. So we really were quite ready to be able to move forward the launch for IZRELA given the timing on the FDA decision for Exposa. So in moving that forward, as Mike mentioned, really what was critical was we did timely research in the first the end of last year and early this year to confirm our go to market approach, very thorough quantitative and qualitative research, thorough work with our opinion leaders, testing out all of our positioning and messaging. And so we really have everything ready to go and really quite confident in our go to market approach and readiness for this Q2 launch.

Speaker 1

Okay. Thank you very much.

Speaker 0

Next question is from Louise Chen of Cantor Fitzgerald. Your line is now open.

Speaker 8

Hi, good afternoon everyone. This is Carvey on for Louise and Cantor. Thank you for taking our questions. Our first question is what are some takeaways you guys gathered from Knight Pharma in the commercialization of EXPAREL in IBS C in Canada that might be important in The States? How should we view the initial uptake of the drug?

Any feedback from provider community would also be helpful. Our second question is on peak annual revenue. You have highlighted the potential peaks, to be at least $500,000,000 We're wondering how long it would take to get to the peak. Thank you so much.

Speaker 2

Susan, that's where in your court.

Speaker 3

Great. Yeah. So the first thing, Canada, actually, the COVID restrictions in Canada have really been quite significant. So while they have stopped the channel for Ibsrela, they really have not fully launched commercially in Canada. So it is too early to say exactly.

The early read in terms of the opinion leader response, the provider research in Canada, the need for an alternative mechanism therapy for IBS C, all the research findings are quite aligned with what we learned in The US. So that's all I can tell you at this time. And what's great is that we are very much aligned with the Canada commercial team for North America alignment on our go to market approach, messaging positioning, communication of the data, and really leveraging the opinion leader community. So we'll continue to keep you posted on that as they are really just starting to ramp up their full commercial launch. In terms of your next question on provider response here in The US, it's really very interesting.

We've conducted both quantitative and qualitative research. It's quite persistent that there is a very established pattern of how to manage these IBS C patients under their care. So keep in mind, I think everybody's accustomed to thinking about this market as a market building market to bring patients into the physician's office to use the prescription therapies that have been available and introduced over the last decade. But what we have to remember now as we look forward to the launch of Ibsrela, what we're looking at is a very established market, hooked market. Patients that are under a physician's care, they see the physician regularly, they churn through a lot of therapies in managing these patients because the symptoms persist.

So what we hear back from doctors is there is an unmet need, particularly along the pain and bloating. There is a high level of interest in a novel mechanism therapy, and a strong intent to adopt the therapy in a very meaningful subset of patients. And what's notable is that we see this not only across the high writing GIs, we see it across high writing non GIs. We also see it across the opinion leader community on a national and regional level. So everything, all of the intelligence and insights are pointing towards this opportunity and the extent to which Ibsrela can address this clinical unmet need.

And with our sales team now deployed across the country, there is a high level of receptivity to meet with our team, an eagerness for physicians to learn about novel mechanism Ibsrela.

Speaker 8

Got it. And just on the final piece, how long should we should it take to get to the peak for for the drug?

Speaker 3

Yes. Sorry. That was your last question. The, yes. So we had projected that over a five year time frame.

Speaker 7

Got it.

Speaker 8

Okay. Thank you so much.

Speaker 6

You.

Speaker 0

Speakers, next question is from the line of Matt Kaplan of Ladenburg Thalmann. Your line is now open.

Speaker 4

Hi. Good afternoon, guys, and thanks for taking questions.

Speaker 1

Hey, Matt.

Speaker 4

Hi. So just wanted to maybe, continue with Susan a little bit. She initially, in her prepared remarks, you said the uptake of Uzarella is going to be driven by unmet need and coverage. Can you talk a little bit about the kind of how how long coverage will take to get in place and what you see kind of coverage levels exiting this year and kind of going into next and and how how we should think about that?

Speaker 3

Yes, thanks for the question, Matt. We're working as we speak now in parallel educating payers on the clinical profile of IBSRELA. We anticipate that IBSRELA ultimately would be carried as tier five specialty tier product. Is really that needs to be our expectation because you have to look at the established nature of the IBS D market. And it's actually quite unusual to have branded products hold such a strong tier two and tier three position, which is what LINZESS and TRULANCE have.

We are not going head to head with that. Again, we are going to market, focus on addressing the clinical unmet need. There is no alternative to Uzrella in the patients who have been managed and are continuing to show persistent symptoms. So that is the value proposition as we bring it forward to payers. Our intention is to contract to secure access and to try to minimize the prior auth and step hurdles.

But we do not intend to match the rebate levels of LINZESS or TRULANCE, and we do not anticipate holding formulary positions that are comparable to theirs. The crux of the opportunity is addressing the unmet need, the novel mechanism drug and the clinical package. So we will be working with payers throughout 2022 to secure access for IBSRELA. And I think as we go into 2023, we'll be able to give you a good read on how things are going with that access picture. With in parallel keeping in mind, that is the introduction of any novel therapy when there's an unmet need.

Prescriptions are filled if the writing physician is willing to go through the medical exception process. So obviously, as part of demonstrating to payers the demand for IBSRELA, which is what will help us secure the access positions we seek, we'll be working very closely with them to give them all the support to really pursue approval of the IBSRELA script via the exception process following launch.

Speaker 4

Okay, that's very helpful. Thank you. And then I guess one more for you, Susan, in terms of what commercial metrics do you plan to share with us on a quarterly basis beyond, I guess, obviously reporting revenues, but helping us, to gauge your success in the launch?

Speaker 3

Yeah. So clearly, reporting revenues is a primary metric that we will be sharing with you. I think we all need to be cognizant of the typical ramp up of accuracy of data capture for IQVIA scripts. And that'll be very much determined by the profile, the mix of use, maybe retail versus specialty, and reporting capture. Over time, as we get to a steady state for IQVIA capture, we will be reporting on our scripts and our share penetration.

Speaker 4

Okay, great. And then just going back to the OND, how does the process work now with OND, until they arrive at a at a answer in April? Is there significant interaction between you and and and that part of the agency?

Speaker 2

Rob?

Speaker 6

Yes. We we've obviously we've we've submitted the appeal, and then we have, it's a potential to have a meeting with them by the end of if they have thirty days to review, so by the end of that process, the potential that we will have a meeting with them, that meeting likely not to be face to face, but we could have a meeting with them. And we could also get, information requests from them asking for more information. So there is plenty of opportunity for interaction with the L and D.

Speaker 4

Okay. That's helpful. Thanks. And then, a quest just a quick question for Justin. He mentioned in his prepared remarks the elimination of the R and D group late last year, and that would have a significant impact on R and D.

Can you help quantify that for us?

Speaker 1

I can't really give specifics out, Matt, yet other than it will be substantially reduced because, as you know, our clinical process, we've wrapped up the preponderance for our work with the phase four programs that David Rosenbaum and Laura led for us, and we aren't doing any novel new research in 2022. So it's gonna be substantially less, than last year.

Speaker 4

Okay. Okay. Thank you. Thanks. Thanks for that detail.

Speaker 2

Thanks, Matt.

Speaker 0

Thank you, participants. I'll now turn the call back over to Michael Robb for final remarks.

Speaker 2

Thank you all for joining our call. This is indeed a transformational year for Ardellix with our launch of Zurella for patients with IBS C. We look forward to keeping you apprised of our progress in the coming months. And Jesse, you may now end the call. Thank you.

Speaker 0

Thank you, speakers. This concludes today's conference call. Thank you all for joining. You may now disconnect.